The Clinical Trials Support Office (CTSO) was established in 2002 to provide support for clinical researchers at the three Fred Hutchinson/University of Washington Cancer Consortium (Consortium) institutions, which are Fred Hutchinson Cancer Research Center (FHCRC), University of Washington (UW), and Children's Hospital and Regional Medical Center (Children's). The overarching goal of the CTSO is to provide the infrastructure to support the conduct of efficient, high-quality, regulatorycompliant clinical trials within the Consortium. Toward this end, the CTSO provides centralized training and education to Cancer Consortium members and research staff on appropriate conduct of clinical trials. The CTSO also provides, on a fee-for-service basis, research study staff to implement and manage all aspects of clinical trials. The CTSO is responsible for the clinical trials monitoring program and for Protocol-Specific Research Support activities. The key functions of the CTSO are to: 1) Provide experienced, knowledgeable staff to facilitate the implementation and management of clinical trials by Consortium investigators. 2) Provide training services to investigators and research staff in the appropriate implementation and management of clinical trials. 3) Conduct monitoring of ongoing clinical trials as mandated by the Consortium NCIapproved data safety and monitoring plan. 4) Provide expertise, personnel and administrative support for initial development of clinical trials programs within the Consortium, with a special emphasis on young investigators and strategically targeted areas. 5) Optimize resources to maximize cost-effective management of clinical trials.